AbbVie (NYSE:ABBV) has announced positive top-line results in a Phase 3 trial focusing on patients with active ankylosing spondylitis (AS), an inflammatory disease that can eventually lead to fused vertebrae.
The first of two studies, the SELECT-AXIS 2 study examined a daily 15-mg dose of Rinvoq (upadacitinib) in AS patients who had an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARD) therapy.
Rinvoq is a Janus kinase (JAK) inhibitor presently FDA indicated for moderately to severely active rheumatoid arthritis patients. The FDA indication specifically covers patients with a prior history of inadequate response or intolerance to the immunosuppressive drug methotrexate.
The study used the Assessment in SpondyloArthritis International Society (ASAS) 40 response by week 14 as a primary endpoint.
A total of 45% of Rinvoq recipients achieved an ASAS40 score at week 14 compared to 18% of placebo recipients. Similarly, 44% of Rinvoq recipients achieved the Ankylosing Spondylitis Disease Activity Score (ASDAS) Low Disease Activity benchmark, while only 10% of the placebo group did.
Rinvoq recipients had statistically significant reductions in back pain and inflammation as well as improvement in physical function and disease activity after 14 weeks.
Ankylosing spondylitis is associated with a significant symptom burden, including severe pain, restricted mobility, and other complications such as heart problems, compression problems, and eye inflammation.
The SELECT-AXIS 2 also met all ranked secondary endpoints.
Safety data were consistent with the previous Phase 3 SELECT-AXIS 1 study.